MAUDE Adverse Event Report: MALEM MEDICAL LTD. BEDWETTING ALARM; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M043

Device Problems Overheating of Device (1437); Vibration (1674)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  Injury  

Event Description

Malem alarm, used for the first time is defective and getting too hot to be safely connected on child's body.The alarm is small and needs to be clipped on shirt, but when the sensor is connected the alarm is vibrating like its shaking.Removing the sensor stops the vibration, but reinserting it restarts.What's noticeable is that the alarm is getting too hot to handle safely.The device is not warm, but hot about 20 minutes from the time the sensor is connected.This so worrisome.I don't know how much hotter it can get.It may catch fire.Replaced batteries but the defect is in the alarm.The company was contacted at least 3 times, but i did not get any reply.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8659355
• MDR Text Key: 146969324
• Report Number: MW5087066
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR